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Association details:
| Biomarker: | NFE2L2 mutation |
|---|---|
| Cancer: | Lung Non-Small Cell Squamous Cancer |
| Drug: | sapanisertib (CB-228) (mTORC1 inhibitor, mTORC2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Calithera Receives FDA Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer
Published date:
10/03/2022
Excerpt:
Calithera Biosciences, Inc...announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for the company’s investigational mTORC 1/2 inhibitor sapanisertib (CB-228) for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors have a mutation in nuclear factor erythroid 2-related factor (NFE2L2, also called NRF2) and who have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy.
Source:
Title:
Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer
Excerpt:
...- Patients must have histologically or cytologically confirmed stage IV or recurrent squamous cell lung cancer or KRAS mutant lung cancer that harbors any of the NFE2L2 mutations or KEAP1 mutations; any KEAP1 mutation will be eligible...
Trial ID:
Source:
Title:
Targeting NFE2L2/KEAP1 mutations in advanced NSCLC with the TORC1/2 inhibitor TAK-228.
Excerpt:
Within SQCLC NFE2L2 pts ORR = 29% (2/7 PR) and DCR = 100%. Prolonged duration of response is present, with PFS = 10.5mo, 11.4mo (18.2mo tx beyond PD), 6mo (8mo tx beyond PD), 5.5mo+, 4.5mo, and 1.5mo+. Within SQCLC KEAP1 pts DCR = 66% (2SD, 1PD) with PFS = 7.4mo+, 3mo+, 1mo.
DOI:
10.1200/JCO.2019.37.15_suppl.9085
Trial ID:
